A Study to Evaluate the Efficacy and Safety of GDC-8264 in Preventing Cardiac Surgery-Associated Acute Kidney Injury (AKI) and Major Adverse Kidney Events (MAKE)

Description

The aim of this study is to evaluate the efficacy and safety of GDC-8264 compared with placebo in participants undergoing cardiac surgery who are determined to be at moderate to high risk of developing AKI and subsequent MAKE at 90 days after surgery (MAKE90). The study will be performed in two parts- Part 1 and Part 2.

Conditions

Acute Kidney Injury

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Study Overview

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Study Details

Study overview

The aim of this study is to evaluate the efficacy and safety of GDC-8264 compared with placebo in participants undergoing cardiac surgery who are determined to be at moderate to high risk of developing AKI and subsequent MAKE at 90 days after surgery (MAKE90). The study will be performed in two parts- Part 1 and Part 2.

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of GDC-8264 in Preventing Cardiac Surgery-Associated Acute Kidney Injury and Major Adverse Kidney Events

A Study to Evaluate the Efficacy and Safety of GDC-8264 in Preventing Cardiac Surgery-Associated Acute Kidney Injury (AKI) and Major Adverse Kidney Events (MAKE)

Condition
Acute Kidney Injury
Intervention / Treatment

-

Contacts and Locations

Springfield

Baystate Cardiac Surgery, Springfield, Massachusetts, United States, 01107

Lincoln

CHI Health Nebraska Heart, Lincoln, Nebraska, United States, 68526-9437

New York

Columbia University Irving Medical Center, New York, New York, United States, 10032

Durham

Duke University Medical Center, Durham, North Carolina, United States, 27705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. One of the following non-emergent cardiac surgery types that requires cardiopulmonary bypass (CPB) to be done in one procedure rather than separate procedures: Isolated Coronary Artery Bypass Grafting (CABG); Isolated surgical Aortic Valve Replacement (AVR), Mitral Valve Replacement (MVR), Mitral Valve repair (MVr); Combined CABG+AVR, CABG+MVR, CABG+MVr, AVR+MVR, AVR+MVr
  • 2. At least one or at least two of the following AKI risk factors, depending on the type of surgery: age \> 70 years, history of CKD with eGFR \< 60 milliliters/ minutes/ 1.73 meter square (ml/min/1.73 m\^2) within the last 6 months, diabetes (type 1 or type 2) requiring at least one oral hypoglycemic agent or insulin, history of chronic obstructive pulmonary disease (COPD) requiring medical therapy, left ventricular ejection fraction (LVEF) \< 40%, preoperative anemia {hemoglobin \<10 milligrans/ deciliters (mg/dL)}
  • 3. Stable kidney function with no known episodes of AKI within 2 weeks of screening
  • 1. Need for renal replacement therapy (peritoneal dialysis or hemodialysis)
  • 2. Need for intra-aortic balloon pump, temporary mechanical circulatory support, or extracorporeal membrane oxygenation prior to scheduled surgery
  • 3. Presence of a durable left ventricular assist device
  • 4. Emergent cardiac surgery
  • 5. Need for concurrent aortic surgery or repair of congenital heart defects
  • 6. Heart transplant
  • 7. Transcatheter valve replacements
  • 8. Hypotension or shock requiring hospital admission
  • 9. Cardiopulmonary resuscitation
  • 10. eGFR \< 20 mL/min/1.73 m\^2
  • 11. Heart failure with ejection fraction \< 20%, or episode of decompensated heart failure requiring intervention within 2 weeks of screening
  • 12. History of kidney transplant or only one kidney (due to donation)

Ages Eligible for Study

40 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Genentech, Inc.,

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

2027-11-15